Perform qualification and validation activities throughout the lifecycle of Drug Substance (DS) and Drug Product (DP) manufacturing facilities of equipment / systems from design through operational use and retirement. Ensure all validation activities are executed in compliance with applicable regulatory requirements, company standards, and industry best practices.
Responsibilities:
1. General:
- Perform qualification and validation activities for the Drug Product and Drug Substance manufacturing facilities in Singapore.
- Ensure compliance with applicable regulatory requirements, company quality standards and validation procedures.
- Collaborate effectively with Engineering, Manufacturing, Quality, and external service providers to deliver validation objectives.
2. C&Q (Singapore Facilities Start-up)
- Develop and execute commissioning and qualification deliverables to support facility start-up and operational readiness.
- Coordinate C&Q activities with internal stakeholders, equipment suppliers, and external service providers.
- Review supplier-generated C&Q documentation and develop qualification protocols and reports where required.
- Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), as required.
- Track validation deliverables and project milestones to ensure timely completion in accordance with project schedules.
- Support the resolution of validation variance / issues in a timely and compliant manner
3. CQV (Singapore Facilities Operation)
- Maintain the qualified state of the equipment / systems through periodic review, re-qualification and continue process verification programs and change control system
- Support client audits, regulatory inspections, and internal audits by providing validation expertise and documentation
- Coordinate and execute qualification and validation activities supporting New Product Introduction, improvement projects, facility modification and shutdown activities
Requirements:
- Diploma, bachelor's degree, or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related discipline.
- Minimum 1 year of relevant validation experience.
- Experience working in facilities operating under FDA, EMA, EU GMP, PIC/S, or equivalent regulatory frameworks.
- Hands-on qualification of manufacturing equipment, cleanrooms, clean air devices, and temperature-controlled units.
- Experience performing smoke visualization studies, temperature mapping, or qualification using data loggers and mapping systems (e.g., Kaye, Ellab). is preferred.
- Basic knowledge and experience of regulatory requirements and industry standards.
- Good understanding of Quality System, EHS.
